Manufacture Smarter Blog

9/13/2019
- BY: ANDY NICHOLS
Commonly, internal quality auditors conduct their audit assignments only to make sure everyone is "following procedures." Unfortunately, this approach fails to address the effectiveness of only doing what is written down. This neglect results in important facets of any QMS being overlooked.

8/2/2019
- BY: DALE WICKER
Even in today's manufacturing world, differing beliefs surrounding quality still exist. One of the most popular myths in the industry is the belief that 'Quality' with a capital Q, is solely the responsibilty of the Quality Department. That is... False! To truly achieve quality in a given product or process, manufacturers must establish quality as a strategic priority throughout the entire organization, not just the Quality Department.

5/17/2019
- BY: ANDY NICHOLS
“Ticking away the moments that make up a dull day…” go the lyrics of Pink Floyd’s song “Time." The meaning behind the song’s lyrics, while strongly applicable to everyday life, also is an apt description for the way certain clauses of ISO 9001:2015 are implemented.

4/12/2019
- BY: STEVE VAMPLEW
Manufacturers face an ongoing, daily challenge to make sure quality is maintained in all of their products and processes. Scheduled management reviews and audits required by a certification body are not always enough to ensure quality is consistently being upheld throughout all levels of the organization. For those manufacturers who wish to go the extra mile with quality, Layered Process Audits are a solution.

3/22/2019
- BY: BOB JENKINS
When it comes to manufacturing, Michigan has a wealth of talent and skills. Many of those skills were established through multiple OEM automobile launches and new product developments. And while the 2008 downturn cost Michigan a lot of skilled performers, they have returned in large part.

3/1/2019
- BY: ANDY NICHOLS
ISO 9001 was released with the visual metaphor of a pyramid often being used to represent the documentation requirements of the standard for Quality Management Systems (QMS). Despite not being a model directly described in the ISO standard or any related guidance, like ISO 9004, some quality teams preferred to envision the hierarchy of documents mentioned in ISO 9001 as a pyramid.

2/15/2019
- BY: RON QUINKERT
As we discussed in a recent blog, many manufacturers are deciding now is the time to diversify. With a potential recession on the horizon, organizations are faced with a few different diversification options to pursue: develop new types of products, sell to new geographic areas or expand into new industries.

12/14/2018
- BY: ANDY NICHOLS
While these lyrics to the Ella Fitzgerald song (or Bananarama, if you prefer) are typically seen in a fun musical context, they also can be applied to a very different context: an ISO 9001 Certification Body Non-Conformity Report. When this report is issued, it is common for an organization to have to respond with a corrective action within a timeframe of 30 days. But what action is really needed?

11/2/2018
- BY: ANDY NICHOLS
The medical device industry is ill! According to the FDA’s medical device recall data, this year alone there have been 22 recalls, tarnishing thousands of medical products. Research also has shown that most of these recalls came from manufacturing-related defects, making this a critical issue for medical device manufacturers to tackle. Recalls like these are costing the industry between $1.3 and $5 billion each year.

9/28/2018
- BY: ANDY NICHOLS
If you are registered to ISO 9001:2015 or one of the quality management requirements built on the international standard, like IATF 16949 or AS9100D, your management must comply with the requirements of the “Management Review” clause 9.3. When complying with this requirement, commonly asked questions include how often and when to do the review.